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Clinical Trials/NCT01651286
NCT01651286CompletedNot Applicable

Determination of the Efficacy of Nasal Mask Ventilation During the Induction of General Anesthesia

Massachusetts General Hospital2 sites in 1 country52 target enrollmentStarted: June 2012Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
52
Locations
2
Primary Endpoint
Tidal volume
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Recently, the investigators demonstrated that nasal route ventilation is superior to the nasal-oral combined ventilation in the absence of jaw thrust and chin up maneuvers. The investigators hypothesize nasal mask ventilation may reduce the incidence of difficult mask ventilation during the induction of general anesthesia by: 1) producing a better seal than full face mask, and 2)establishing a greater airway patency and more effectively ventilate than full face mask ventilation. The investigators intend to test this hypothesis on adult patients during the induction of general anesthesia in the absence of muscle relaxation.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •18-65 years of age
  • •ASA physical status classification I-II
  • •general anesthesia
  • •elective surgery
  • •who are able to breathe through both their nose and mouth while awake

Exclusion Criteria

  • •Patients with major cardiovascular disease, respiratory disease, cerebral vascular disease or American Society of Anesthesiologists physical status class III or greater.
  • •Abnormal vital signs on the day of admission for surgery [heart rate (HR, >100 bpm or <40 bpm), blood pressure (BP, >180/100 mmHg or <90/60 mmHg), room air transcutaneous oxyhemoglobin saturation (SPO2) <96%] that are not correctable with his or her routine medication or commonly used pre-operative medication.
  • •Unable to open mouth (<2.5 cm) or unable to breathe through their mouth or nose.
  • •Any person with an anticipated difficult airway. This will include subjects that require or may require either a fiberoptic intubation or intubation while awake.
  • •Gastric-esophageal reflex or a full stomach.
  • •Neurological symptoms associated with neck extension, a neurological deficit from a previous stroke or spinal cord injury, a recent stroke or Transient Ischemic Attack (TIA) within 2 weeks.
  • •Pregnant women and women less than one month post-partum. Ruling out pregnancy will be conducted by careful history and physical examination as performed routinely prior to surgery. If the history is believed to be unreliable, the patient will be excluded unless a pregnancy test is performed and the result of the test is negative.
  • •Emergency cases and subjects who have not adhered to the ASA NPO (Nil Per Os - Nothing By Mouth) guidelines.

Outcomes

Primary Outcomes

Tidal volume

Time Frame: in 30 minutes after the induction of general anesthesia

Tidal volume generated by the positive pressure ventilation during the induction of general anesthesia

Secondary Outcomes

  • success rate of positive pressure ventilation with different masks(in 30 minute after the induction of general anesthesia)
  • Carbon dioxide removal(in 30 minutes after the induction of general anesthesia)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yandong Jiang

Assistant Professor

Massachusetts General Hospital

Study Sites (2)

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